Type2diabetes, SGLT2 Inhibitor, Urinary Tract InfectionNCT05520684
Asymptomatic Bacteriuria, Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors and UTI Risk
An observational study of Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection, run by Trabzon Arakli Bayram Halil Public Hospital at 1 site in Turkey (Türkiye).
Trial summary
The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection
- What is being tested?
- urine culture and urinalysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The female Type 2 Diabetes Mellitus patients followed and initiated SGLT2 inhibitors by an internal medicine specialist in a public hospital covering a district
Who may be able to join
- Female
- >18 years old
- Type 2 Diabetes Mellitus
- Initiated SGLT2 inhibitors
- Available informed consent
Who cannot join
- Having urinary tract or genital tract symptoms at the enrollment
- Treated for urinary tract or genital tract infection in the last 3 months
Trial locations and contacts
1 site in 1 country.
Erman Akkus, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Trabzon Araklı Bayram Halil Public Hospital
Trabzon
Erman Akkus, MD
About this study
Official title: Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors
The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.
- Being tested
- urine culture and urinalysis
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine culture and urinalysisDiagnostic test
urine culture and urinalysis
| Study group | Role | What they receive |
|---|---|---|
| positive for bacteriuria/ urinalysis abnormality | The patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) Receives: Diagnostic Test: urine culture and urinalysis | |
| negative for bacteriuria/ urinalysis abnormality | The patients who do not have growth in urine culture or do not have abnormality in urinalysis at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) Receives: Diagnostic Test: urine culture and urinalysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection
Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start15 Feb 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetes, SGLT2 Inhibitor, Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trabzon Arakli Bayram Halil Public Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erman Akkus, Trabzon Arakli Bayram Halil Public Hospital
- Investigators
- Erman Akkus, MD, Study chair, Trabzon Arakli Bayram Halil Public Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520684
- Sponsor's protocol ID
- 6111449
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Infection Risk in Women With Asymptomatic Bacteriuria or Urinalysis Abnormality at the Initiation of SGLT2 Inhibitors
- ClinicalTrials.gov ID
- NCT05520684
- Acronym / sponsor ID
- 6111449
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Trabzon Arakli Bayram Halil Public HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SGLT2 inhibitors have changed the treatment of type 2 diabetes mellitus in recent years, especially in patients with cardiovascular or renal disease. However, the association between SGLT2 inhibitors and urinary tract infection (UTI) risk is controversial. Moreover, it is not known whether asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors are risk factors for UTI in women. There is not enough data to recommend or not to recommend for performing urinalysis or urine culture test before initiation of SGLT2 inhibitors. The aim of the study is to investigate the effect of asymptomatic bacteriuria or urinalysis abnormality at the initiation of SGLT2 inhibitors on UTI risk in a prospective cohort of women with type 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| positive for bacteriuria/ urinalysis abnormality | – | Diagnostic Test: urine culture and urinalysisThe patients who have any growth in urine culture or urinalysis abnormality at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) |
| negative for bacteriuria/ urinalysis abnormality | – | Diagnostic Test: urine culture and urinalysisThe patients who do not have growth in urine culture or do not have abnormality in urinalysis at the initiation of SGLT2 inhibitor (dapagliflozin or empagliflozin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The female Type 2 Diabetes Mellitus patients followed and initiated SGLT2 inhibitors by an internal medicine specialist in a public hospital covering a district
Key inclusion criteria (5 listed)
- Female
- >18 years old
- Type 2 Diabetes Mellitus
- Initiated SGLT2 inhibitors
- Available informed consent
Key exclusion criteria (2 listed)
- Having urinary tract or genital tract symptoms at the enrollment
- Treated for urinary tract or genital tract infection in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine culture and urinalysisurine culture and urinalysis | Diagnostic test | negative for bacteriuria/ urinalysis abnormality, positive for bacteriuria/ urinalysis abnormality |
Primary outcome
Urinary tract infection
Time frame: 3 months
Number of participants with urinary tract infection - Any urinary tract infection treated or diagnosed by the physician clinically or by testing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erman Akkus, MD contact
Erman Akkus, MD study chair
Trabzon Arakli Bayram Halil Public Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes, SGLT2 Inhibitor, Urinary Tract Infection, run by Trabzon Arakli Bayram Halil Public Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erman Akkus, MD (erman_akkus@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.